Clinical Trials (Phase III)
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Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease. -
Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial. -
Rakuten Medical to Start a Global Phase 3 Trial of Alluminox™ Treatment using ASP-1929 for Recurrent Head and Neck Cancer in India
5/22/2023
Rakuten Medical, Inc. (Rakuten Medical) today announced that the Company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical trial (ASP-1929-301/ClinicalTrials.gov Identifier: NCT03769506) evaluating Alluminox treatment (photoimmunotherapy) using ASP-1929 in patients with locoregional.
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Corium's Novel ADHD Medication AZSTARYS® (Serdexmethylphenidate and Dexmethylphenidate) Had No Clinically Significant Impact on Children's Weight and Height Growth Rate
5/22/2023
Corium, LLC announced that an analysis of a long-term, 12-month, open-label Phase 3 study of children aged 6-12 using its novel attention-deficit hyperactivity disorder (ADHD) medication AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) showed no clinically significant impact on weight and height growth rate in pediatric patients.
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PolyPid Announces FDA Agreement on the Design of SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections
5/22/2023
PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) agreed to Company’s SHIELD II Phase 3 trial design evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs).
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Valbiotis Announces the Large Success of the REVERSE-IT International Multicentric Phase II/III Clinical Study on TOTUM•63: Proven Efficacy on the Main Risk Factor of Developing Type 2 Diabetes
5/22/2023
Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible) (Paris:ALVAL), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the large success of the REVERSE-IT Phase II/III clinical study on TOTUM•63.
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RedHill Provides R&D Update
5/22/2023
RedHill has elected to terminate RHB-204's U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to low accrual rate and plans to shift resources to more rapidly advance RHB-107 late-stage development for outpatient treatment of COVID-19.
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Corvia Medical Releases Two-year Clinical Trial Results Confirming Sustained Benefit and Safety of Its Atrial Shunt in Heart Failure Patients
5/22/2023
Corvia Medical, Inc, a company dedicated to transforming the treatment of heart failure, announced two-year results from its REDUCE LAP-HF II randomized clinical trial confirming safety and sustained efficacy of the Corvia® Atrial Shunt in properly selected heart failure patients with preserved or mildly reduced ejection fraction.
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Oculis Announces Positive Top Line Results from DIAMOND Stage 1 Phase 3 Trial in Diabetic Macular Edema with OCS-01 Eye Drops
5/22/2023
Oculis Holding AG, a global biopharmaceutical company purposefully driven to save sight and improve eye care, announced positive top line results from Stage 1 of its Phase 3 DIAMOND trial of OCS-01 eye drops in Diabetic Macular Edema.
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Dupixent® (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine
5/21/2023
Regeneron Pharmaceuticals, Inc. and Sanofi presented positive Phase 3 results evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation.
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Press Release: Dupixent® (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine
5/21/2023
Positive Phase 3 results evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation were shared in the 2023 American Thoracic Society International Conference session “New England Journal of Medicine and JAMA.
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In a 12-2 vote with two abstentions, the advisers said the benefits did not outweigh the risks. -
Alnylam Presents 18-Month Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy
5/20/2023
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced new results from an interim analysis of exploratory data from the open-label extension period of the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy.
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Neurocrine Biosciences Announces Publication of Full KINECT™-HD Phase 3 Study Results of Valbenazine for the Treatment of Chorea Associated with Huntington's Disease in The Lancet Neurology
5/19/2023
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that the complete study results from its Phase 3 KINECT™-HD study investigating valbenazine for the treatment of chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue.
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HanAll Biopharma Announces Results from Phase III randomized, double-masked active treatment-controlled VELOS-3 Trial Evaluating Tanfanercept 0.25% for Treatment of Dry Eye Disease
5/19/2023
HanAll Biopharma Co., Ltd. announced results from the Phase III VELOS-3 trial evaluating the safety and efficacy of tanfanercept, a novel, topical anti-inflammatory treatment being studied for the treatment of dry eye disease (DED) in subjects diagnosed with moderate to severe DED.
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Sebela Women's Health Announces Positive Phase 3 Data for its Investigational, Next-Generation, Hormone-Free, Low-Dose Copper Intrauterine Device (IUD)
5/18/2023
Sebela Women's Health Inc. today announced positive results of a Phase 3 study demonstrating that investigational Copper 175 mm2 IUD met the primary efficacy outcome measurement of prevention of pregnancy through 3 years of use, with a cumulative 3-year Pearl Index (number of pregnancies per 100 women over 1 year) of 0.96 (95% CI, 0.59-1.48) or 99% efficacy.
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FibroGen Announces Positive Topline Results from China Pivotal Phase 3 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia
5/18/2023
FibroGen, Inc. today announced positive topline data from Company’s Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies in China.
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The Phase III trial met its primary endpoint, a significant reduction of phenylalanine levels in the blood, with no severe adverse events reported, PTC Therapeutics reported Wednesday. -
NImmune Biopharma Provides Update on Omilancor Clinical Development Programs in Ulcerative Colitis and Crohn’s Disease
5/17/2023
NImmune Biopharma today announced Phase 2 data on an approvable population of ulcerative colitis (UC) patients and its plans to initiate a registration directed global Phase 3 program for omilancor for the treatment of UC.
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PTC Therapeutics Announces APHENITY Trial Achieved Primary Endpoint with Sepiapterin in PKU Patients
5/17/2023
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the primary endpoint was achieved in the APHENITY, Phase 3 registration-directed clinical trial of sepiapterin in adult and pediatric patients with phenylketonuria (PKU).